P-089: EVALUATION OF SAFETY AND EFFICACY OF HBS-SAILIN®: A POTENT INGENIOUS ANTI-SICKLING AGENT THAT REDUCES PAIN AND IMPROVES THE QUALITY OF LIFE IN SICKLE CELL PATIENTS.
Authors: BHATT S., RAJESH A., BHANSALI A., BENEDICT N., MEHER S., PANDA P., DASH B., KUNDU S.
Journal: HemaSphere (2022)

Purpose: WHO and UN have recognized Sickle cell disease (SCD) as a global health pandemic, with approximately 2/3 of 300,000 children born annually in Africa and India, projected to climb to 400,000 by 2050. Inadequate healthcare, poor nutrition and infections aggravate the disease burden, resulting in 30% of morbidity in the under-five age group. Current medication is insufficient, expensive, or inflicts one with lasting toxicity. The present study investigates the anti-sickling effect of HbS-Sailin® (Patent Application:WO/2017/125791A1). Materials and methods: We evaluated the in-vitro anti-sickling efficacy of HbS-Sailin® in SCD derived RBCs. Subsequently, animal toxicological studies were carried out in compliance with OECD-GLP guidelines at Shriram Institute for Industrial Research. A two-site open-labeled, non-randomized clinical observation trial (NCT) of HbS-Sailin® for a 12-week period was undertaken at National Institute for Pharmaceutical Research and Development (NIPRD), Abuja, Nigeria (Africa) and at the University of Benin Teaching Hospital, Benin (Africa) to determine its safety, efficacy, and tolerability in SCD patients of the Nigerian population. Results: It inhibited the 85% of erythrocyte sickling at 0·5 mg/ml. It also delayed the rate of polymerization of HbS molecules which is indicative that the formulation has the ability to hinder the process of hypoxia-induced polymerization of sickle hemoglobin. The decreased osmotic fragility indicates the decreased hemolysis in the presence HbS-Sailin. Incubation of RBCs with various concentrations of Sailin-HbS® did not dehydrate RBCs, cause hemolysis, or form met-Hb. Further, acute, sub-acute, and chronic toxicity analysis was performed in swiss mice and Wistar rats. All the animals administered were with the graded doses of 200, 500, 1000, and 2000mg/kg did not induce any observable toxic effects when compared to its corresponding control group of animals. Hence, may be considered as “No Observed Adverse Effect Level” N.O.A.E.L. ≥1000 mg/kg b.wt.Oral administration of HbS-Sailin® in 44 patients with SCD in a 12-week study increased hemoglobin levels, a remarkable decrease in reticulocytes, and an irreversible sickle cell population which suggests less hemolysis. A drastic reduction in a bone pain crisis, SCD related adverse events, hospital admissions, blood transfusions and enhanced the perception of QOL. Conclusion: Affordable therapeutic and management strategies for SCD have evolved very slowly, and the treatment of SCD remains a severe unmet medical need. Given the outcome of this study, HbS-Sailin® may be a promising option for the treatment and management of patients with SCD.Fig 1. The morphology of sickle cells that were incubated under hypoxic conditions in the absence or presence of various concentrations of Sailin-HbS after 4hrs observed under 40x magnification.Fig 2. Clinical profile of sickle cell patients administered with Sailin-HbS. The authors do not declare any conflict of interest